Skip to main content
SpringerLink
Log in

The BCS, BDDCS, and Regulatory Guidances

  • Commentary
  • Published:
Pharmaceutical Research Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

REFERENCES

  1. Amidon GL, Lennernäs H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutics drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 1995;12:413–20.

    Article  PubMed  CAS  Google Scholar 

  2. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. 2000 August. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070246.pdf.

  3. Committee for Medicinal Products for Human Use, European Medicines Agency. Guideline on the Investigation of Bioequivalence. 2010 January 20. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf.

  4. Wu CY, Benet LZ. Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a Biopharmaceutics Drug Disposition Classification System. Pharm Res. 2005;22:11–23.

    Article  PubMed  CAS  Google Scholar 

  5. Benet LZ, Amidon GL, Barends DM, Lennernäs H, Polli JE, Shah VP, et al. The use of BDDCS in classifying the permeability of marketed drugs. Pharm Res. 2008;52(3):483–8.

    Article  Google Scholar 

  6. Takagi T, Ramachandran C, Bermejo M, Yamashita S, Yu LX, Amidon GL. A provisional biopharmaceutical classification of the top 200 oral drug products in the United States, Great Britain, Spain and Japan. Mol Pharm. 2006;3:631–43.

    Article  PubMed  CAS  Google Scholar 

  7. Chen ML, Yu L. The use of drug metabolism for prediction of intestinal permeability. Mol Pharm. 2009;6:74–81.

    Article  PubMed  CAS  Google Scholar 

  8. Yan Y, Faustino PJ, Volpe DA, Lyon RC, Yu LX. Biopharmaceutics classification of selected beta-blockers: Solubility and permeability class membership. Mol Pharm. 2007;4:608–14.

    Article  Google Scholar 

  9. Lennernäs H. Intestinal permeability and its relevance for absorption and elimination. Xenobiotica. 2007;37:1015–51.

    Article  PubMed  Google Scholar 

  10. Lennernäs H. Human jejunal effective permeability and its correlation with preclinical drug absorption models. J Pharm Pharmacol. 1997;49:627–38.

    Article  PubMed  Google Scholar 

  11. Dahan A, Miller JM, Hilfinger JM, Yamashita S, Yu LX, Lennernäs H, et al. High-permeability criterion for BCS classification: Segmental/pH dependent permeability consideration. Mol Pharm. 2010;7:1827–34.

    Article  CAS  Google Scholar 

  12. Artursson P, Palm K, Luthman K. Caco-2 monolayers in experimental and theoretical predictions of drug transport. Adv Drug Deliv Rev. 2001;46:27–43.

    Article  PubMed  CAS  Google Scholar 

  13. Khandelwal A, Bahadduri PM, Chang C, Polli JE, Swaan PW, Ekins S. Computational models to assign biopharmaceutics drug disposition classification from molecular structure. Pharm Res. 2007;24:2249–62.

    Article  PubMed  CAS  Google Scholar 

  14. Oprea TI, Tropsha A, Faulon J-L, Rintoul MD. Systems chemical biology. Nat Chem Biol. 2007;3:447–50.

    Article  PubMed  CAS  Google Scholar 

  15. Oprea TI, May EE, Leitão A, Tropsha A. Computational systems chemical biology. Meth Mol Biol. 2011;672:459–88.

    Article  CAS  Google Scholar 

  16. Lennernäs H, Abrahamsson B. The use of biopharmaceutic classification of drugs in drug discovery and development: current status and future extension. J Pharm Pharmacol. 2005;57:273–85.

    Article  PubMed  Google Scholar 

  17. Blume HH, Schug BS. The biopharmaceutics classification system (BCS): Class III drugs – better candidates for BA/BE waiver? Eur J Pharm Sci. 1999;9:117–21.

    Article  PubMed  CAS  Google Scholar 

  18. Yu LX, Amidon GL, Polli JE, Zhao H, Mehta MU, Conner DP, et al. Biopharmaceutics Classification System: The scientific basis for biowaiver extensions. Pharm Res. 2002;19(7):921–5.

    Article  PubMed  CAS  Google Scholar 

  19. Yazdanian M, Briggs K, Jankovsky C, Hawi A. The “high solubility” definition of the current FDA Guidance on Biopharmaceutical Classification System may be too strict for acidic drugs. Pharm Res. 2004;21:293–9.

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Rm. 4108, Silver Spring, Maryland, 20993-0002, USA

    Mei-Ling Chen

  2. College of Pharmacy, University of Michigan, Ann Arbor, Michigan, USA

    Gordon L. Amidon

  3. Department of Bioengineering and Therapeutic Sciences Schools of Pharmacy and Medicine, University of California - San Francisco, San Francisco, California, USA

    Leslie Z. Benet

  4. Department of Pharmacy, Uppsala University, Uppsala, Sweden

    Hans Lennernas

  5. Office of Generic Drugs, Office of Pharmaceutical Science Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA

    Lawrence X. Yu

Authors
  1. Mei-Ling Chen
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Gordon L. Amidon
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Leslie Z. Benet
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Hans Lennernas
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Lawrence X. Yu
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Mei-Ling Chen.

Additional information

This paper was written partly based on the discussions from an Open Forum held at the 2010 PSWC/AAPS Annual Meeting, New Orleans. The opinions expressed in this article do not necessarily represent the views or policies of the U.S. Food and Drug Administration.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Chen, ML., Amidon, G.L., Benet, L.Z. et al. The BCS, BDDCS, and Regulatory Guidances. Pharm Res 28, 1774–1778 (2011). https://doi.org/10.1007/s11095-011-0438-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11095-011-0438-1

KEY WORDS

Search

Navigation